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IRCT20091229002924N3 IRCT 2024-01-17 Bojnourd University of Medical Sciences Investigating the effect of magnesium supplementation on stress and ovulation The Investigating the effect of magnesium supplementation on stress and ovulation rate in infertile women with polycystic ovary syndrome 2024-02-20 anticipated 108 Complete https://irct.ir/trial/74975 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Other, Randomization description: Allocation of samples to intervention and placebo groups will be done using the random block method with blocks of 4 and using the website www.sealedenvelope.com. In this study, with a ratio of 1:1, the samples will be divided into intervention and placebo groups, Blinding description: In order to hide the random allocation, sealed opaque envelopes with a random sequence will be used among the selected people to enter the two groups. Also, in the implementation of the random allocation process, the person involved in the creation of the randomization program will be separate from other researchers to reduce the possible bias of the person creating the random sequence.In order to blind the study, before the start of the study, a set of cans containing the relevant tablets (magnesium tablets) and placebo (containing Avicel and lactose), which are completely similar to magnesium tablets in terms of shape, size and color, and manufactured by Sina Pharmaceutical Company was coded by a person other than the researcher as A (intervention group) and B (placebo group) to ensure that the researcher did not know the type of pills received in each group. Each participant is given a package containing 112 tablets (magnesium/placebo) for 8 weeks and is advised to take two tablets daily from the same day. The intervention group will take magnesium supplements twice a day in the form of magnesium oxide tablets (each tablet contains 250 mg of elemental magnesium) and the control group will take placebo tablets for 8 weeks. In order not to inform the participants of the study, magnesium supplement tablets and placebo will have similar appearance and at the first glance of an expert, they will look completely identical. 3 Polycystic Ovary Syndrome. Intervention 1: Intervention group: The intervention group receives magnesium supplements twice a day in the form of magnesium oxide tablets (each tablet contains 250 mg of elemental magnesium). Intervention 2: . Intervention 3: Control group: The control group will take placebo pills for 8 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Maryam Hassanzadeh Bashtian
Shahriyar St. school of Nursing. Midwifery Department.
Bojnurd Iran (Islamic Republic of) 94176-96786 +98 58 3229 7097 m.h.Bashtian@gmail.com Bojnourd University of Medical Sciences scientific Maryam Hassanzadeh Bashtian
Shahriyar St. School of Medicinie & Nursing . Midwifery Department.
Bojnurd Iran (Islamic Republic of) 94176-96786 +98 58 3229 7097 m.h.bashtian@gmail.com Bojnourd University of Medical Sciences Iran (Islamic Republic of) Infertility for more than a year Absence of acute and chronic diseases, Not using medicinal compounds and supplements containing magnesium. Not taking anti-anxiety and sedative drugs. Not using drugs, tobacco and alcohol. Not using relaxation techniques. Body mass index less than 35, Magnesium intake less than 75% of the recommended dietary intake 18 years 45 years Female Pregnancy, Use of oral contraceptive pills, Occurrence of any severe stress (for example, divorce or death of a relative), Personal desire to withdraw from the study during the study, Consumption of less than 90 out of 112 magnesium supplement tablets or placebo. E28.2 Polycystic ovarian syndrome Treatment - Drugs Treatment - Drugs Intervention group: The intervention group receives magnesium supplements twice a day in the form of magnesium oxide tablets (each tablet contains 250 mg of elemental magnesium). Control group: The control group will take placebo pills for 8 weeks. To determine the effect of magnesium supplementation on stress and ovulation rate in infertile women with polycystic ovary syndrome. Timepoint: Newton's stress questionnaire first and then 4 weeks after taking the pills and at the end of taking the pills.Vaginal ultrasound at the beginning of the study as an entry criterion and then 4 weeks after taking the pills and then between the 10th and 14th day of the trigger drug cycle. Method of measurement: Ultrasound, Newton stress questionnaire. Bojnourd University of Medical Sciences Approved 2023-12-27 Ethical committee of North Khorasan University of Medical Sciences Shahid Vaghefi street. Dolat Blvd. North Khorasan University of Medical Sciences. Bojnurd North Khorasan Iran (Islamic Republic of)